FDA 483 - Hikma Pharmaceuticals USA Inc. - November 03, 2023

Hikma Pharmaceuticals USA Inc., a human sterile drug manufacturer in Cherry Hill, NJ, received an FDA Form 483 with five observations. The firm demonstrated significant deficiencies in component identity testing, failed to thoroughly investigate unexplained discrepancies related to stability and dissolution, and exhibited poor equipment cleaning and maintenance. Additionally, the company did not submit Field Alert Reports in a timely manner and lacked proper identification for laboratory samples, indicating systemic quality control and compliance issues.